UMIN-CTR Clinical Trial

Basic information
Public title	Analysis study of factors implicated in skin trouble on infants.
Acronym	Analysis study of factors implicated in skin trouble on infants.
Scientific Title	Analysis study of factors implicated in skin trouble on infants.
Scientific Title:Acronym	Analysis study of factors implicated in skin trouble on infants.
Region	Japan

Condition
Condition	Healthy infants
Classification by specialty	Dermatology Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identification of factors implicated in skin trouble.
Basic objectives2	Others
Basic objectives -Others	Identification of factors implicated in skin trouble.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Screen subjects from each group of skin trouble-susceptible infants and non-susceptible infants based on medical questionnaire and diagnosis. Then, perform composition analysis of stratum corneum and feces of them.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	-Diagnosis of skin symptom. -Composition analysis of stratum corneum. -Analysis of resident skin bacteria. -Composition analysis of feces and saliva. -Questionnaire survey about lifestyle and constitution.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	4 months-old <=
Age-upper limit	8 months-old >=
Gender	Male and Female
Key inclusion criteria	-Infant with use of disposable diaper. -Healthy infant without any disorder outside of skin. -Both infants likely to develop skin trouble and infants unlikely to develop skin trouble.
Key exclusion criteria	-Infants with chronic disorder. -Infants with serious skin symptom requiring treatment. -Infants with infectious disorder. -Infants deemed inappropriate to participate in this study by the physician-in-charge.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoko Baba
Organization	Kanagawa Children's Medical Center
Division name	Department of dermatology
Zip code
Address	4-1124-2 Mutsukawa, Minami-ku, Yokohama, Kanagawa, Japan 232-0066
TEL	045-711-2351
Email	nbaba@kcmc.jp

Public contact
Name of contact person	1st name Middle name Last name Tatsuya Honda
Organization	DRC Co., Ltd.
Division name	Evaluation Center
Zip code
Address	2-6 Koubaicho, Kita-ku, Osaka, Japan 530-0038
TEL	06-6882-1130
Homepage URL
Email	honda@drc-web.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 22 Day
Date of IRB	2016 Year 02 Month 22 Day
Anticipated trial start date	2016 Year 03 Month 25 Day
Last follow-up date	2017 Year 05 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	For the purpose of identification of factors implicated in skin trouble, recruit skin trouble-susceptible infants and non-susceptible infants by 30 (total 60 infants).

Management information
Registered date	2016 Year 04 Month 04 Day
Last modified on	2019 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025101